Apparatus for sterile material exchange

ABSTRACT

An apparatus for the sterile material exchange in solutions, which comprises a conventional membrane in form of a hose, a grid of synthetic material, and a hollow empty hose of synthetic material. The conventional membrane is disposed between the grid of synthetic material and is received in the hose of synthetic material. Hose connections are carried by the hose of synthetic material and are capable of being closed by a protection cap. A sealing device closes jointly both the hoses, and both hoses permit an access capable of closing by another protection cap to the membrane connection. In one embodiment of the apparatus, the hoses are bent at substantially a right angle for insertion into the sealing or closing device. The invention also includes the system of hoses being wound in a double spiral about two tubes of synthetic material.

Russmann et al.

[451 Dec.'12, 1972 APPARATUS FOR STERILE MATERIAL EXCHANGE Inventors: Horst Russmann, Neu Isenburg} Helmut Determann, Frankfurt am Main, both of Germany Biotest-Serum-Institut Frankfurt/Main-Niederrad,

many

Filed: March 4, 1970 Appl. No.: 16,331

Assignee: GmbH,

Ger-

Foreign Application Priority Data March 6, 1969 Austria"; ..A 2242/69 US. Cl ..210/32l, 23/2585 Int. Cl. ..B01 d 31/00 Field of search ..210/22, 23, 321, 541; 23/2585 References Cited I UNITED STATES PATENTS i I FOREIGN PATENTS OR APPLICATIONS 1,527,944 4/1968 .Francc ..2l0/32l Primary Examiner-Frank A. Spear, Jr. Attorney-Ernest G. Montague [5 7] ABSTRACT An apparatus for the sterile material exchange in solutions, which comprises a conventional membrane in form of a hose, a grid of synthetic material, and a hollow empty hose of synthetic material. The conventional membrane is disposed between the grid of synthetic material and is received in the hose of synthetic material. Hose connections are carried by the hose of synthetic material and arecapable of being closed by a protection cap. A sealing device closes jointly both the hoses, and both hoses permit an access capable of closing by another protection cap to the membrane connection. In one embodiment of the apparatus, the hoses are bent at substantially a right angle for insertion into the sealing or closing device.

' The invention also includes the system of hoses being 11 Claims, 9 Drawing Figures PATENTED um 12 I972 SHEET 1 BF 2 ill:

FIG. IA.

FIG. 2A.

INVENTORS HORST RUSSMANN H LMUT DETERMANN ATTORNEY.

PA'TENTED DEC 12 I972 UT DETERMANN FIG. 2.

' A INVENTORS HORST RUSSMANN ATTORNEY.

The present invention relates to an apparatus for sterile material exchange, in general, and to such material exchange in solutions, in particular.

No apparatus is known, which permits a convenient and sterile dialysis in a technical measure. Known devices for themost different dialysis problems are always large and non-handy arrangements of complicated combinations. All these arrangements are not provided as devices for a single use, rather for a plurality of or permanent applications.

The apparatus designed in accordance with the present invention is suitable for the insulation of macro-molecular substances from solutions, in particular of biological material mixtures, for example, the dialysis in enzyme preparations, the hemo-dialysis, the laboratory-like technical dialysis in biology, biochemistry and medicine, for the concentration of solutions of any type by ultra-filtration, as oxygen generator and generally for the gas exchange in solutions.

For the heme-dialysis at the present time two different forms of dialysis are provided: The Kill-dialysis and the Coildialysis. It is attempted in both embodiments, to distribute a smallest possible quantity of blood to a possible large face of an exchange membrane available on the market, and to permit rinsing of this membrane on the other side by a rinsing liquid, the so-called dialysis liquid.

The known oxygenerators are nearly always complicated combined devices, which are used many times merely for reason of costs.

Essential requirements for the dialysis and the gas exchange are:

1. Separation of the material currents by a membrane.

2. A large exchange area at a small volume of the liquid to be dialyzed or provided for the gas exchange.

3. A great effectiveness of the material exchange while possibly most intensive contact of both exchange media with the exchange membrane and free selection of the current guide.

4. For exchange problem the suitable exchange area.

5. Possibly small loss of the substance to be treated upon termination of the exchange by remaining in the exchange unit.

6. Low pressure loss in the device.

7. Free selection of the flow cross-section and of the flow speed.

8. The possibility, to vary the pressures on both sides of the membrane and to control thereby the ultra-filtration.

9. Free selection of the exchange membranes.

l0. Possibility of sterilization.

11. Small unit in comparison with the exchange effect.

12. The apparatus ready for use should be transparent, in order to make possible the observation of the exchange processes.

All these requirements are not fulfilled by any of the known devices and apparatus.

It is one object of the present invention to provide an apparatus for sterile material exchange which operates with a conventional membrane.

With this and other objects in view, which will become apparent in the following detailed description, the present invention, which is disclosed by example only, will be clearly understood in connection with the accompanying drawings, in which:

FIG. 1 is one embodiment of the apparatus, designed in accordance with the present invention, shown by example only;

FIG. 2 is a section of the sealing device through which the hose of synthetic material is closed.

FIG. 2A is a cross-section along section 2A of. FIG. 2B.

FIG. 2B is a cross-section along section 28 of FIG. 2A.

FIG. 3 is an elevation of another embodiment of the hose-system; and

FIG. 4 is anelevation, partly in section, of another embodiment of the apparatus, designed in accordance with the present invention.

FIG. 4A is a cross-section along section 4A of FIG. 4.

. FIG. 4B is a cross-section along section 4B of FIG.

4A. I v

Referring now to the drawings,,and in particular to FIG. 1,the apparatus for the sterile material exchange in solutions of synthetic material is characterized by the feature, that a conventional membrane 1 in form of a hose is disposed between a grid 2 of synthetic material and is inserted into a hose 3 of synthetic material, which hose 3 has hose connections 4 closable with a conventional protection cap. Either both hoses are closed on both sides jointly by a sealing device 5, which permits an access 6 closable with. a protective cap to the membrane hose or two accesses 6a and 6b are provided only at one side of the apparatus, which accesses make possible the approach to a hose.

The grid 2 of synthetic material can also be disposed between two foils 3a of synthetic material, which are then welded during the manufacture of the apparatus on both sides of the grid material to form a hose.

The membrane, provided in accordance with the present invention, should permit for dialysis purposes the passage of small molecules from one solution into the other." Thereby the macromolecules should be retained. For this purpose many membranes are available on the market, in particular products of celluloseregenerates or cellulose-derivates are suitable, for example, the product marketed by the firm Bemberg of Wuppertal, Germany, under the name Cuprophan.

For the gas exchange by the apparatus, designed in accordance with the present invention, any transparent material is suitable as a membrane, which retains liquids and dissolved material, preferably silicone rubber.

The inner space should be as much as possible completely compressed thereby, so that the total width of the hose, a passage possibility for the gas or the solution in a narrow split is assured. Suitable grid mate-rials have, for example, a waffle-like structure, as the produce marketed under the name of poly-net-grid material by the firm Norddeutsche 'Seekabelwerke AG, Nordenham, Germany.

The task of the grid synthetic material, to produce a rigid distance between the outer skin of the hose of synthetic material and the exchange membrane, so that a free flow cross-section for the rinsing liquid and the gas stream, respectively, is provided.

For the unit, it is in principle of no importance, whether the rinsing liquid and the gas, respectively, and the liquid to be treated flow in counter or parallel current. Since, however, due to the structure of the unit a very intensive contact of both media with the exchange membrane, and which is obtained in particular over its entirev length, due to the greater effectiveness by the larger concentration gradients, countercurrent operation is more advantageous. The grid material and the exchange area are, as mentioned already, adjustable to a special exchange problem. This applies of course, also for the exchange membrane. Thus, one has three values to be varied independently from each other, with which values possibly specific information can be given about a product to be I treated and specific exchange effects can be obtained, respectively.

The apparatus can be sterilized in the inner space andin the outer space and can therefore be applied for any type of the material exchange.

Referring now to the drawings, FIG. 1 shows an embodiment of the present apparatus by example only. In this embodiment the rinsing liquid and the gas, respectively, enters at one end of the hose 3 of synthetic material and emerges on the other end. If the hose 3 of synthetic material is compressed from the outside, simultaneously the membrane hose 1 is formed to a very flat, non-uniformly mounted flat-hose by the grid 2 of synthetic material engaging both sides. It is arranged, thereby, that the unit contains only a small quantity of liquid to be treated. In order to maintain the inner space in the membrane hose 1 at the ends as small as possible, itis inserted advantageously with the hose 3 of synthetic material at a right angle into the closing device 5. If the exchange is terminated, the unit is suspended perpendicularly and the liquid to be treated can escape nearly completely. With a rinsing media in addition a washing can be performed and this washing process can be observed by the totally transparent unit. The pressure loss in the membrane hose 1, related to the solution, depends directly upon the length of the hose and its free cross-section. Since both values are variable, the pressure loss can be maintained extremely low. Since the liquid to be treated can be fed by its gravity force, as well as by means of a pump through the membrane hose 1, also a higher pressure loss in the unit can be overcome. If the unit is very long, the pressure loss caused thereby can be overcome by application of a pump. By the driving force (gravity force, pump) as well as by throttling of the output, the passage-quantity and-speed in the pressure ratio in the unit can be varied and be adjusted to the product. The same applies for the flow conditions outside of the exchange membrane 1. The possibility exists, to adjust the passage quantity, the passage speed and the free cross-section of the outer flow space by suitable grid material 2 to the product to be treated. It is added, that the rinsing liquid and the gas, respectively, can press or suck through the hose 3 of synthetic material and, thereby, can exert an influence upon the effect of the ultra-filtration by control of the pressure conditions within and without the membrane hose 1.

Referring now again to the drawings, and in particular to FIG. 2, sealing devices are disclosed, by which the hoses of synthetic material are closed. These sealing devices are advantageously machined of synthetic material or injection molded. The screws, with which the sealing device can be compressed can be formed of any suitable material, in particular metal or synthetic material.

In order to obtain a possibly hand and compact embodiment of the exchanger, it is desirable, in particular in longer units, to wind up the hose system in form of a double spiral, in order to wind two tubes 8 of synthetic material and to tie the same rigidly. This embodiment is disclosed in FIG. 3 of the drawings. Upon termination of the exchange, the tying can be loosened and the unit can be emptied and rinsed, respectively.

Referring now to FIG. 4 of the drawings, a selected possibility of an embodiment of the present invention is shown, as an apparatus which has at one side only two accesses 6a and 6b, which make possible the access to the individual hoses. This embodiment has the advantage of greater handiness, in particular in longer units.

The apparatus, designed in accordance with the present invention, fulfills the above-stated requirements in a satisfactory manner. It is to be understood, however, that the used materials is physiologically perfect, and that the apparatus is provided for a sterile use. With the apparatus, designed in accordance with the present invention, it is possible to maintain sterile also the used rinsing solution.

Since for an exchange process, it is of greatimportance, how often the rinsing liquid and the gas, respectively, and the liquid to be treated is fed through the exchanger, a great advantage can be seen in the fact, that in the apparatus, designed in accordance with the present invention, .all parts can be varied as to size and form, for example, also the hose width and the hose length. By the great number of the parameter of the described unit, optimum conditions, often by a single passage only through the apparatus, can be determined by merely a few tests for any application, and a predetermined exchange with fixed flow conditions can be selected.

It is to be understood that also a plurality of units can be switched in series.

While we have disclosed several embodiments of the present invention, it is to be understood that these embodiments are given by example only and not in a limiting sense.

We claim:

I. A dialysis apparatus for sterile material exchange using at least one solution, comprising an inner permeable membrane in the form of a ho]- low empty hose,

a grid of synthetic material,

a non-rigid outer hose of synthetic material,

said grid of synthetic material being interposed between said inner and outer hoses,

hose connections carried by said hose of synthetic material and adapted to be closed by a protection cap,

c a closing device which set both said hoses,

both said hoses permitting an access adapted to be closed by another protection cap to the membrane connection, and

the ends of said inner and outer hoses being bent at substantially a right angle for insertion into said closing device.

2. The apparatus, as set forth in claim 1, wherein said access is disposed on both sides of said hoses.

3. The apparatus, as set forth in claim 1, wherein two accesses are disposed on one side only.

4. The apparatus, as set forth in claim 1, wherein said hose of synthetic material comprises two foils welded together.

5. The apparatus, as set forth in claim 1, wherein said membrane comprises a material selected from the group consisting of a regenerated cellulose and a cellulose derivate.

6. The apparatus, as set forth in claim 1, wherein said membrane is permeable to gases and comprises silicone rubber.

'7. The apparatus, as set forth in claim 1, which includes a grid of synthetic material comprising poly-netgrid material.

8. The apparatus, as set forth in claim 1, wherein one of said inner and outer-spaces is sterile.

9. The apparatus, as set forth in claim 1, wherein said hose of synthetic material has from both sides hose connections capable of being closed at both ends, and

said hose connections close up also said hose membrane.

10. The apparatus, as set forth in claim 1, wherein said hose of synthetic material has at one side closable hose connections,

one of said hose connections leads to said hose, and

the other of said hose connections leads to said membrane.

l l. A dialysis apparatus for sterile material exchange using at least one solution comprising an inner permeable membrane in the form of a hollow empty hose,

a grid of synthetic material,

a non-rigid outer hose of synthetic material,

said grid of synthetic material being interposed between said inner and outer hoses,

hose connections carried by said hose of synthetic material and adapted 'to be closed by a protection cap,-

a closing device which closes both said hoses,

both said hoses permitting an access adapted to be closed by another protection cap to the membrane connection, and

system of said hoses being wound in a double spiral about two tubes of synthetic material.

the system of said hoses being wound in a double spiral about two tubes of synthetic material. 

1. A dialysis apparatus for sterile material exchange using at least one solution, comprising an inner permeable membrane in the form of a hollow empty hose, a grid of synthetic material, a non-rigid outer hose of synthetic material, said grid of synthetic material being interposed between said inner and outer hoses, hose connections carried by said hose of synthetic material and adapted to be closed by a protection cap, c a closing device which set both said hoses, both said hoses permitting an access adapted to be closed by another protection cap to the membrane connection, and the ends of said inner and outer hoses being bent at substantially a right angle for insertion into said closing device.
 2. The apparatus, as set forth in claim 1, wherein said access is disposed on both sides of said hoses.
 3. The apparatus, as set forth in claim 1, wherein two accesses are disposed on one side only.
 4. The apparatus, as set forth in claim 1, wherein said hose of synthetic material comprises two foils welded together.
 5. The apparatus, as set forth in claim 1, wherein said membrane comprises a material selected from the group consisting of a regenerated cellulose and a cellulose derivate.
 6. The apparatus, as set forth in claim 1, wherein said membrane is permeable to gases and comprises silicone rubber.
 7. The apparatus, as set forth in claim 1, which includes a grid of synthetic material comprising poly-net-grid material.
 8. The apparatus, as set forth in claim 1, wherein one of said inner- and outer-spaces is sterile.
 9. The apparatus, as set forth in claim 1, wherein said hose of synthetic material has from both sides hose connections capable of being closed at both ends, and said hose connections close up also said hose membrane.
 10. The apparatus, as set forth in claim 1, wherein said hose of synthetic material has at one side closable hose connections, one of said hose connections leads to said hose, and the other of said hose connections leads to said membrane.
 11. A dialysis apparatus for sterile material exchange using at least one solution comprising an inner permeable membrane in the form of a hollow empty hose, a grid of synthetic material, a non-rigid outer hose of synthetic material, said grid of synthetic material being interposed between said inner and outer hoses, hose connections carried by said hose of synthetic material and adapted to be closed by a protection cap, a closing device which closes both said hoses, both said hoses permittinG an access adapted to be closed by another protection cap to the membrane connection, and system of said hoses being wound in a double spiral about two tubes of synthetic material. the system of said hoses being wound in a double spiral about two tubes of synthetic material. 